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FDA STARLIX NDA 021204 Approval Package — Reviews & Approval Records

FDA STARLIX NDA 021204 Approval Package — Reviews & Approval Records

$229.00 USD
$229.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for STARLIX, NDA 021204. The package contains 21 FDA documents totaling 255 pages, organized by original application and supplemental submission.

Research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

  • Original FDA approval records
  • 9 supplemental submissions represented
  • 1 FDA review document
  • 10 approval letters
  • 10 labeling documents
  • FOIAdocs document index and detailed manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: NDA 021204
Product: STARLIX
Sponsor: NOVARTIS
Documents: 21
Pages: 255
Coverage: Original approval + 9 supplemental submissions represented
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